Dual-antiplatelet Therapy Strategies for Elective PCI in... | NCT05559918

Studies
Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting

NCT05559918

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Unknown status

Last Update Posted

Apr 24, 2024Actual

Enrollment

1,462Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Jul 30, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Sep 21, 2022

First Submission Date that Met QC Criteria

Sep 26, 2022

First Posted Date

Sep 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2024

Last Update Posted Date

Apr 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ronak Delewi, Principal Investigator Dr. R Delewi, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Principal Investigator

Lead Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the safety and efficacy of in-laboratory clopidogrel loading dose administration before ad-hoc PCI versus clopidogrel preloading treatment in patients planned for diagnostic angiography with optional ad-hoc PCI.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,462Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Net adverse clinical events (NACE)	The incidence rate of NACE (the composite of the clinical events all-cause death, myocardial infarction, definite/probable stent thrombosis, stroke and BARC type 2, -3 or -5 bleeding) wil be compared between groups at 30 days	30 days

Secondary Outcomes

Measure	Description	Time Frame
Bleeding (classified as BARC type 2, -3 and -5 bleeding)	The incidence rate of bleeding (classified as BARC type 2, -3 and -5 bleeding) will be compared between groups	In-hospital, at 30 days
Patient oriented clinical events (POCE)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult men and women aged at least 18 years
Scheduled for diagnostic CAG due to suspected obstructive coronary artery disease

Exclusion Criteria:

Presence of contra-indications for the use of clopidogrel (hypersensitivity or known allergy to clopidogrel, severe liver insufficiency, resent or active pathological bleeding, patients known to be poor CYP2C19 metabolizers, patients using pharmacological CYP2C19 inhibitors and inducers)
Patients using clopidogrel for other reasons than the scheduled diagnostic CAG (e.g. due to previous stroke)
Patients using P2Y12 inhibitors other than clopidogrel (e.g. prasugrel, ticagrelor, cangrelor)
Patients using VKA (e.g. acenocoumarol, fenprocoumon)
Patients using DOAC/NOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)
Inability to give informed consent (e.g., language barrier)
Patients who have a documented mentioning of previous denial to any trial participation in the electronic patient dossier

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients aged 18 years and older who have been referred for diagnostic CAG due to symptoms suggestive of obstructive coronary artery disease with optional ad-hoc PCI.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ronak Delewi, MD, PhD	Contact	+31(0)20 566 9111		r.delewi@amsterdamumc.nl

Overall Officials

Name	Affiliation	Role
Ronak Delewi, MD, PhD	Amsterdam University Medical Center, location AMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC	Recruiting	Amsterdam	North Holland		Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Preloading with clopidogrel
In-hospital loading with clopidogrel